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Articles (5733)

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1-10 of 5733 results for Drug Applications

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Select article: Applications of the Orphan Drug Act to Special Patient Populations

Retricted access

Research article

First published 1994-4

Applications of the Orphan Drug Act to Special Patient Populations

Marlene E. Haffner

Therapeutic Innovation & Regulatory Science

Select article: The 505(b)(2) New Drug Application

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Other

First published 2007-5

The 505(b)(2) New Drug Application

J. Christopher Prue, Arthur J. Mayorga

Therapeutic Innovation & Regulatory Science

Select article: The Role of Data Organization in the Evaluation of Toxicology Studies in Drug Application

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Research article

First published 1983-7

The Role of Data Organization in the Evaluation of Toxicology Studies in Drug Application

Vera C. Glocklin

Therapeutic Innovation & Regulatory Science

Select article: Mobile Medical Applications for Dosage Recommendation,Drug Adverse Reaction,and Drug Interaction

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Research article

First published 2017-7

Mobile Medical Applications for Dosage Recommendation,Drug Adverse Reaction,and Drug Interaction

Nur Amirah Apidi, Muthu Kumar Murugiah, Rajendran Muthuveloo [...]

Therapeutic Innovation & Regulatory Science

Select article: Statistics,Quality Review Issues,and Beyond for Generic Drug Applications in Taiwan

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Research article

First published 2013-11

Statistics,Quality Review Issues,and Beyond for Generic Drug Applications in Taiwan

Lin-Chau Chang, Churn-Shiouh Gau

Therapeutic Innovation & Regulatory Science

Select article: Transaction Cost Analysis of the New Drug Application Process

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Research article

First published 2014-5

Transaction Cost Analysis of the New Drug Application Process

Shota Hamada, Akiko Shibata, Hisashi Urushihara [...]

Therapeutic Innovation & Regulatory Science

Select article: Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council

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Research article

First published 2017-7

Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council

Yasuyuki Hattori, Hideki Hanaoka, Yoshiaki Uyama

Therapeutic Innovation & Regulatory Science

Select article: ‘Old Drugs for New Applications’ : Can Orthopedic Research Benefit from This Strategy?

Free access

Review article

First published 2011-8

‘Old Drugs for New Applications’ : Can Orthopedic Research Benefit from This Strategy?

Xiaohua Pan, Wenxiang Cheng, Jiali Wang [...]

Therapeutic Advances in Musculoskeletal Disease

Select article: Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

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Research article

First published 2019-3

Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

Jun Wang, Gang Wang, Min Li [...]

Therapeutic Innovation & Regulatory Science

Select article: Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

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Research article

First published 2019-1

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

Lewis J. Fermaglich, Ru Chen, Carol Y. Kim [...]

Therapeutic Innovation & Regulatory Science

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